Graft Collection and Containment System for Bone Defects

ABSTRACT

A device for containing bone graft material comprises a body including an inner sleeve extending longitudinally from a proximal end to a distal end and an outer sleeve surrounding the inner sleeve and extending longitudinally from a proximal end to a distal end such that a bone graft collecting space is formed therebetween.

BACKGROUND

The present application claims priority to U.S. Provisional ApplicationSer. No. 61/413,590 filed on Nov. 15, 2010 and entitled “GraftCollection and Containment System for Bone Defects,” the entiredisclosure of which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to the treatment of bone defects and, inparticular, relates to treatments using bone grafts.

BACKGROUND

Large bone defects are often treated with metal implants and/or bonegrafts to assist with healing of the bone. The bone grafts may be placedin the target area using any of a variety of methods. For example, agraft may simply be placed between two separated ends of an injured orotherwise damaged bone. However, without a container for the bone graft,the graft may fall away before it can be utilized by the body. Accordingto another method, PMMA spacers may be placed in the target area so thatthe body may form its own fibrous tissue within the spacers,Subsequently, the PMMA spacers are removed and bone graft material ispacked into the capsule formed by the body. Alternatively, some methodshave included a mesh placed into the target area to contain the bonegraft material at that location. These mesh containers generally includean outer wall with a diameter selected to match an outer surface of thebone to prevent the graft material from falling out of the bone.

SUMMARY OF THE INVENTION

The present invention is directed to a device for containing hone graftmaterial comprising a body including an inner sleeve extendinglongitudinally from a proximal end to a distal end and an outer sleevesurrounding the inner sleeve and extending longitudinally from aproximal end to a distal end such that a bone graft collecting space isformed therebetween.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a graft container according to afirst exemplary embodiment of the present invention;

FIG. 2 shows a top view of the graft container of FIG. 1;

FIG. 3 shows a perspective view of the graft container of FIG. 1 with agraft collection system according to the present embodiment;

FIG. 4 shows a perspective view of the graft container and collectionsystem of FIG. 3, with a cover removed;

FIG. 5 shows a perspective view of the system of Fig, 1, with a plungerfor packing in a bone graft;

FIG. 6 shows a side view of a graft container according to a secondexemplary embodiment of the present invention;

FIG. 7 shows a side view of the graft container of FIG. 6 according to athird exemplary embodiment of the present invention;

FIG. 8 shows a side view of a graft container according to a fourthexemplary embodiment of the present invention;

FIG. 9 shows a perspective view of a graft container according to afifth exemplary embodiment of the present invention;

FIG. 10 shows a perspective view of a graft container according to asixth exemplary embodiment of the present invention;

FIG. 11 shows a perspective view of a graft container according to aseventh exemplary embodiment of the present invention;

FIG. 12 shows a perspective view of a graft container according to aneighth exemplary embodiment of the present invention;

FIG. 13 shows a perspective view of an assembled graft container and tipaccording to a ninth exemplary embodiment of the present invention;

FIG. 14 shows a perspective view of the graft container of FIG. 13;

FIG. 15 shows a perspective view of the tip of FIG. 13;

FIG. 16 shows a perspective view of a tip according to an alternateembodiment of the present invention;

FIG. 17 shows a perspective view of a graft container according to atenth exemplary embodiment the present invention;

FIG. 18 shows a perspective view of the graft container of FIG. 17;

FIG. 19 shows a perspective view of a graft container according aneleventh exemplary embodiment of the present invention;

FIG. 20 shows a cross-sectional view of a graft container according to atwelfth exemplary embodiment of the present invention;

FIG. 21 shows a cross-sectional view of a graft container according to athirteenth exemplary embodiment of the present invention;

FIG. 22 shows a perspective view of the graft container of FIG. 21;

FIG. 23 shows a perspective view of a graft container according to afourteenth exemplary embodiment of the present invention;

FIG. 24 shows a perspective view of a graft container according to afifteenth exemplary embodiment of the present invention;

FIG. 25 shows a perspective view of the graft container of FIG. 24, afirst and second clam-shell portion thereof separated from one another;

FIG. 26 shows a perspective view of a graft container according to asixteenth exemplary embodiment of the present invention;

FIG. 27 shows a perspective view of a graft container according to aseventeenth exemplary embodiment of the present invention;

FIG. 28 shows a perspective view of a graft container according to afurther embodiment of the present invention;

FIG. 29 shows a perspective view of an adaptor for the system of FIG. 1,according to a further embodiment of the present invention; and

FIG. 30 shows a perspective view of a graft container formed using anexemplary method of the present invention.

DETAILED DESCRIPTION

The present invention may be further understood with reference to thefollowing description and the appended drawings, wherein like elementsare referred to with the same reference numerals. The present inventionrelates to the treatment of bone defects and, in particular, relates totreatments using bone grafts. Exemplary embodiments of the presentinvention describe a bone graft collection and containment systemcomprising a double-walled graft container for receiving and holdinggraft material between an inner and outer wall thereof to prevent excessgraft material from being lost in a medullary canal of the target boneand to facilitate the flow of nutrients to the graft

As shown in FIGS. 1-2, a graft system 100 comprises a graft container102 configured to be positioned between separated longitudinal portionsof a bone at a target spot at which a graft is to be made to join theseparated portion of the target bone. For example, the container 102 maybe formed as a double-walled vessel sized and shaped to match thecontours of the target bone. Specifically, an outer sleeve 114 of thecontainer 102 is preferably shaped to substantially match a profile ofouter surfaces of the target portions of bone adjacent to the site ofthe graft. For a long tubular bone, the outer sleeve 114 will besubstantially cylindrical with an outer diameter substantially matchingthat of the adjacent portions of bone. The container 102 furtherincludes an inner sleeve 112 separated from the outer sleeve 114 by anannular space 132 within which bone graft material is to be held. Theinner sleeve 112 is substantially tubular with a diameter selected tosubstantially match an inner diameter of a medullary canal of the boneto prevent bone graft material from being lost from the graft area intothe medullary canal enhancing the incorporation of the graft materialinto the bone.

The inner sleeve 112 of the container 102 extends longitudinally from aproximal end 116 to a distal end 118 and defines a central lumen 120radially therewithin. In a preferred embodiment, the container 102 maybe sized and shaped for treating a femur. For example, the inner andouter sleeves 114, 112 may be substantially tubular and substantiallyequal to one another in length such that proximal ends 116, 122correspond to one another in position longitudinally and distal ends118, 124 also correspond to one another in position longitudinally. Theinner and outer sleeves 112, 114 are connected to one another via one ormore ribs 134 extending between the inner and outer sleeves 112, 114along at least a portion of the length thereof. In a preferredembodiment, the container 102 includes four ribs 134 connecting theinner and outer sleeves 112, 114, which are equally spaced relative toone another about a circumference of the container 102. A diameter of aninner surface 128 of the lumen 126 of the outer sleeve 114 is largerthan a diameter of an outer surface 130 of the inner sleeve 112 by anamount selected to form an annular space 132 therebetween for collectingthe bone graft material.

The container 102 may further include a notch 121 extending through atleast one of the proximal ends 116, 122 of the inner and outer sleeves112, 114, respectively, and a tab 125 extending distally from at leastone of the distal ends 118, 124 the inner and outer sleeves 112, 114,respectively. The notch 121 and the tab 125 may correspond in size andshape such that, if desired, one ore more containers 102 may be stackedlongitudinally to increase a bone graft length. The notch 121 of a firstcontainer 102 interfaces with the tab 125 of a second container 102. Ina preferred embodiment, the container 102 includes two notches 121diametrically opposed to one another and two tabs 125 similarlydiametrically opposed to one another.

The inner and outer sleeves 112, 114 preferably include holes 158extending therethrough to permit evacuation of blood and irrigationfluids during graft material collection, while also permitting nutrientsto flow into the bone graft material collected in the space 132 fromradially outside and inside the container 102. It will be understood bythose of skill in the art that the hoes 158 are sized to permit the flowof nutrients therethrough while preventing the bone graft material frompassing therethrough. For example, the diameter of the holes may be inthe range of 0.5 to 2.0 mm and spaced apart from one another in a rangeof between 4.0 mm to 8.0 mm. As would be understood by those skilled inthe art, the container 102 may be formed of any suitably strongbio-compatible material such as a polymer or a metal and may also bebioresorbable. In another embodiment, the inner and outer sleeves 112,114 may be formed of a porous material or mesh material so that holes158 are not necessary. In yet another embodiment, the container 102 maybe formed of a flexible material. In one exemplary embodiment, the outersleeve 114 may be formed of a substantially rigid material while theinner sleeve 112 is formed of a flexible material such that the innersleeve 112 may adapt to a size and shape of, for example, anintramedullary rod inserted through a medullary canal of a bone. Thecontainer 102 may be formed of polymer materials such as, for example,Polyglycolic Acid (PGA), Poly Lactic Acid (PLA), Polycaprolactone (PCL)or any similarly acting polymers or copolymers. The container 102 mayalso be formed of collagen or polyurethane. The container 102 may alsobe formed of a metal such as, for example, a bioresorbable magnesium ornon-resorbable metals such as an implantable titanium or stainlesssteel. In yet another embodiment, the container 102 may be fabricatedfrom donor bone, e.g., specifically fabricated allograft or xenograftmaterials. In another embodiment, the container 102 may be formed ofmaterials such as ceramic or polyetherertherketone (PEEK).

As shown in FIGS. 3-5, the graft system 100 may further comprise a graftcollection system 101 for collecting graft material and loading it intothe space 132 of the container 102. The graft collection system 100includes a canister 104 into which the container 102 is placed forfilling with bone graft material. A flow directing element 108 isincluded within the canister 104 for guiding the graft material drawninto the canister 104 into the space 132 of the container 102.Specifically, a proximal end 142 of the canister 104, which is directedtoward a patient, is connected to a suctioning element 106 while asuctioning device is connected to a distal end 140 thereof, which isdirected away from the patient, to draw a suctioning force through thecanister 104 and the container 102 received therein. The suctioningelement 106 may be positioned at a gathering site within a body of thepatient while the suctioning device at the distal end 140 is positionedoutside of the patient body. The suctioning element 106 may be connectedto any known reaming device (not shown) gathering graft material whichis suctioned from the gathering site through a tube such as thesuctioning element 106 connected to the proximal end 142 of the canister104. The flow directing element 108 directs the flow of suctionedmaterial (i.e., bone graft material) entering the canister 104 into theannular space 132 of the container 102 so that the collection of bonegraft material and its packing into the container 102 is completed in asingle step. The system 100 may optionally include a plunger 110 forpacking the bone graft material in the container 102 although suchmanual packing may not be necessary.

The canister 104 includes a body 136 and a cover 138. The body 136extends longitudinally from the distal end 140 to the proximal end 142and includes a channel 144 extending therethrough sized and shaped toreceive the container 102 therein. The distal end 140 may include aconnector 146 such as, for example, a barb connector, for connecting thecanister 104 to a tube which is connected to a secondary canister whichis connected to a vacuum source. It will be understood by those of skillin the art, however, that the connector 146 may be any connectingmechanism capable of connecting the canister 104 to a vacuum tube forapplying the suctioning force through the canister 104. The proximal end142 is configured to releasably couple to the cover 138 such that thecover 138 may remain connected to the body 136 during a bone graftcollection process but may be removed once the container 102 has beenfilled with a desired amount of the bone graft material.

The cover 138 may also include a connector 148 extending from a proximalsurface of the cover 138 to connect to the suctioning element 106. Thecover 138 may further include a protrusion extending distally from adistal surface of the cover 138 sized and shaped to surround theproximal end of the container 102 such that bone graft materialsuctioned via the suctioning element 106 is directed into the space 132of the container 102. The suctioning element 106 may, for example, be asubstantially tubular element extending from a distal end 150 thatcoupled to the connector 148 of the cover 138 to a proximal end 152,which may be connected to a reamer as those skilled in the art willunderstand so that material reamed by the reamer be drawn thereintounder suction applied through the canister 104,

The flow directing element 108 includes a base portion 154 and a shaftportion 156 extending proximally therefrom. The shaft portion 156 may beinserted into the lumen 120 of the inner sleeve 112 to direct bone graftmaterial into the space 132 of the container 112. The base portion 154may include a substantially planar proximal surface 160 and a pluralityof legs 162 extending from a distal surface 164 thereof. The legs 162prevents the distal surface 164 of the base portion 154 from blockingthe suctioning force received via the connector 146 at the distal end140 of the canister 104 when the container 102 and the flow directingelement 108 are received in the canister 104. The shaft portion 156 maybe inserted into the lumen 120 until the proximal surface 160 of thebase portion 154 abuts the distal end of the container 102 and aproximal end 164 of the shaft portion 156 extends proximally past theproximal end 118 of the inner sleeve 112. The proximal end 164 of theshaft portion 156 may include a tapered tip (e.g., a conical tip) todirect bone graft material received via the suctioning element 106 awayfrom the lumen 120 and into the space 132. The proximal surface 160prevents bone graft material from being suctioned distally therepastsuch that bone graft material is collected in the space 132.

As shown in FIG. 5, once a desired amount of bone graft material hasbeen collected in the space 132, the cover 138 and the suctioningelement 106 may be detached from the body 136 of the canister 104,exposing the container 102. If desired, the user may then use theplunger 110 to pack the bone graft material in the container 102 toachieve a desired degree of packing of the bone graft material withinthe space 132. The plunger 110 may include a handle portion 166 and abody 168. The body 168 may extend longitudinally from a distal end (notshown) to a proximal end 170. The body 168 is sized and shaped tocorrespond to a size and shape of the space 132 such that the user mayinsert the body 168 in the space 132, moving the body 168 distally intothe space 132 such that the bone graft material is packed therein. Forexample, the body 168 may be substantially tubular, including at leastone longitudinally extending slit 172 for accommodating the rib 134extending longitudinally between the inner and outer sleeves 112, 114.It will be understood by those of skill in the art, however, that thebody 168 may be of a variety of shapes and sizes so long as the body 168corresponds to a size and shape of the space 132 permitting the body 168to be inserted therein to pack the bone graft material. The handleportion 166 extends proximally from the body 168 and may include, forexample, a knob 172 to facilitate gripping of the handle portion 166 bythe user, it will be understood by those of skill in the art, however,that the handle portion 166 may include any of a variety ofconfigurations so long as the handle portion 166 may be gripped by auser to move the plunger 110 longitudinally relative to the container102.

According to an exemplary technique utilizing the system 100, the userfills the container 102 with bone graft material utilizing the system100, as described above. Specifically, the shaft 156 of the flowdirecting element 108 is inserted into the lumen 120 of the inner sleeve112 so that flow directing element 108 and the container 102 are placedin the body 136 of the canister 104. The base portion 154 of the flowdirecting element 108 is positioned at the distal end 140 of thecanister 104 such that the legs 162 raise the base portion 154 away fromthe distal end 140 to permit a suctioning force from an opening at thedistal end 140 to pass through the canister 104. Once the container 102and the flow directing element 108 have been properly positioned in thebody 136, the cover 138 is attached to the proximal end 142 of the body136. The connector 148 extending from the cover 138 is then coupled tothe suctioning element 106 which is coupled to a reamer in aconventional manner. The connector 146 at the distal end 140 is thencoupled to a suctioning device to draw a suctioning force through thecanister 104 and the suctioning element 106.

Once the system 100 has been assembled, as described above, the reameris used to harvest bone graft material which is immediately suctionedfrom the reamer into the canister 104 as described above. The taperedproximal end 157 of the shaft portion 156 of the flow directing element108 directs the fluid and bone graft material received through thesuctioning element 106 away from the inner lumen 120 and into the space132 between the inner and outer sleeves 112, 114. The fluid is suctionedout of the container 102 via the holes 158 thereof such that only thebone graft material remains in the space 132. The suctioned fluid may besuctioned out of the canister 104 and into the secondary canister, whichis attached to the suctioning device. Once a desired amount of bonegraft material has been collected in the space 132, the user may employthe plunger 110 to pack the bone graft material in the container 102 byinserting the body 168 of the plunger 110 into the space 132 and movingthe plunger 110 distally relative to the container 102 until the desireddegree of packing has been achieved. After the bone material has beencollected and packed in the container 102, the container 102 may bepositioned in a bone defect to treat the defective bone.

As shown in FIG. 6, a container 202 according to a further embodiment ofthe invention is substantially similar to the container 102 describedabove except that the container 202 further includes a plurality ofslits 276 extending partially circumferentially through portions theinner sleeve (not shown) and the outer sleeve 214. The slits 276 in thisembodiment are formed in planes substantially perpendicular to alongitudinal axis L and increase the flexibility of the container 202along the axis L facilitating handling and insertion of the container202 into the target bone. In addition, tins longitudinal flexibilitycompensates for slight size mismatches between the container 202 and theportion of bone it is to replace while permitting a desired amount ofstrain to be transferred to the bone graft to stimulate bone growthrather than shielding the bone graft from strain. As shown in FIG. 7, acontainer 202′ according to a further embodiment of the inventionincludes, in place of the circumferential slots of the container 202, aplurality of slits 276′ extending substantially parallel to the axis Lalong a portion of a length of the container 202′. The longitudinallyextending slits 276′ permit axial compression of the container 202′while the circumferential slits 276, as shown in FIG. 6, permit thecontainer 202 to flex during handling and implantation. Those skilled inthe art will understand that the flexibility of the container 202 willdiffer from that of the container 202′.

As shown in FIG. 8, a container 302 according to a still furtherembodiment of the invention is substantially similar to the container102 described above except that the inner sleeve 312 is longer than theouter sleeve 314 such that a proximal end 316 of the inner sleeve 312extends proximally beyond a proximal end 322 of the outer sleeve 314 anda distal end 318 of the inner sleeve 312 extends distally beyond adistal end 324 of the outer sleeve 314 so that the proximal and distalends 316, 318 of the inner sleeve 312 may be inserted into the medullarycanal of the target bone to hold the container 302 in place whilepermitting the bone graft material to move within a space 332 formedbetween the inner and outer sleeves 312, 314. Those skilled in the artwill understand that a container may alternatively include an extendedinner sleeve on only one end if desired,

As shown in FIG. 9, a container 302′ according to a still furtherembodiment is substantially similar to the container 302 described aboveexcept that it includes a slot 378′ extending longitudinally through aproximal end 316′ of an inner sleeve 312′ that extends proximally past aproximal end 322′ of an outer sleeve 314′. Additionally, the container302′ includes a slot 380′ extending longitudinally through a distal end318′ of the inner sleeve 312′, which extends distally past a distal end324′ of the outer sleeve 314′. The slot 378′ forms a pair of jaws 316a′, 316 b′ spaced apart form one another and which may be substantiallysemi-circular. The jaws 316 a′, 316 b′ are biased toward the spacedapart configuration, but are movable toward one another such that theproximal end 316′ for insertion into the medullary canal by pressing the316 a′, 316 b′ slightly together. Similarly, the slot 380′ splits thedistal end 318′ into two jaws 318 a′, 318 b′ that are spaced apart fromone another and may be substantially semi-circular. The jaws 318 a′, 318b are biased toward a spaced condition in which they are spaced from oneanother but are movable relative to one another so that the jaws 318 a′,318 b′ may be moved together and inserted into the medullary canal ofthe bone. Once within the medullary canal, the proximal portions 316 a′,316 b′ and the distal portions 318 a′, 318 b′ revert to their biased,spaced apart configuration to form a friction fit with the bone lockingthe container 302′ in place.

As shown in FIG. 10, a container 302″ is substantially similar to thecontainer 302′ but includes a plurality of slots 378″, 380″ extendingthrough each of the proximal and distal ends 316″, 318″ of the innersleeve 312″, Thus, each of the proximal and distal ends 316″, 318″includes a plurality of jaws movable relative to one another. Inaddition, the proximal and distal ends 316″, 318″ are substantiallyspherical to facilitate insertion into the medullary canal whilemaintaining a friction fit with the canal once inserted.

As shown in FIG. 11, a container 402 according to another exemplaryembodiment of the present invention is substantially similar to thecontainer 102 except that the outer sleeve 414 includes a reinforcedsection 482 extending along a length thereof. The reinforced section 482includes a wall thicker than a wall of a remaining portion of the outersleeve 414. The reinforced section 482 may be formed of a solidmaterial, providing additional support such that fixation elements(e.g., screws) may be drilled therethrough when fixing a plate or otherstabilizing element therealong to maintain the container 402 in positionwithin a target portion of bone. As shown in FIG. 12, according to afurther embodiment, a container 402′ may also include an elongatedopening 484′ through a reinforced section 482′ to permit insertion offixation elements therethrough without requiring a user to drill throughthe thick rib section 482′.

According to another exemplary embodiment of the present invention, asshown in FIGS. 13-15, a system 500 is substantially similar to thesystem 100 except that the system 500 includes a tip 586 attachable to aproximal and/or distal end 516, 518 of an inner sleeve 512 of thecontainer 502 for insertion into a medullary canal. Similarly to thecontainer 102, the container 502, as shown in FIGS. 13-14, includes anouter sleeve 514 surrounding the inner sleeve 512 such that a bone graftmaterial holding space 532 is formed therebetween. In contrast to theholes 158 shown extending through the outer wall 114, holes 558 of thecontainer 502 may be formed as slotted perforation extending through theouter sleeve 514 and/or the inner sleeve 512. Each of the slottedperforations 558 extends about a portion of a circumference of one ofthe sleeves 512, 514, providing an opening for fluid flow into and/orout of the space 532. For example, the slotted perforations 558 may beapproximately 1 mm wide (in a direction parallel to a longitudinal axisof the container 502) while extending circumferentially from 3 mm to 30mm to permit nutrients, blood and irrigant flow while preventing bonegraft material from passing therethrough.

As shown in FIG. 15, the tip 586 includes a first portion 588 configuredto connect to one of the proximal and distal ends 516, 518 of the innersleeve 512 and a second portion 590 adapted and configured for insertioninto the medullary canal. The first portion 588 is sized and shaped tofit around the selected one of the proximal end 516 and the distal end518 of the inner sleeve 512 and, if necessary, includes a plurality ofrecesses 592 sized and located to receive the ribs 534 which connect theinner and outer sleeves 512, 514. Once a desired amount of bone graftmaterial has been packed in the space 532, the tip 586 is attached tothe container 502 by sliding the first portion 588 over the selected oneof the proximal and distal ends 516, 518 with the ribs 534 received inthe recesses 592. The second portion 590 may include a plurality of jaws594 spaced apart from one another such that the second portion 590 maybe inserted into the canal of the bone via a friction fit as describedabove.

In an alternate embodiment, as shown in FIG. 16, a tip 586′ includes afirst portion 588′ for connecting the tip 586′ to the container 502 anda second portion 590′ for insertion into the medullary canal. The firstportion 588′, however, is sized and shaped to fit within a lumen 520 ofthe proximal and distal ends 516, 518, rather than around the sleeve512.

As shown in FIGS. 17-18, in another embodiment, a container 602 issubstantially similar to the container 102 described above except thatthe container 602 includes an inner sleeve 612 and an outer sleeve 614that are two separate parts assembled together to form the container602. The inner sleeve 612 includes ribs 634 extending radially outwardfrom an outer surface 630 thereof along a length of the inner sleeve 612while the outer sleeve 614 includes corresponding rib receiving recesses635 extending longitudinally along an inner surface 626 thereofpositioned to correspond to the ribs 634. To assemble the container 602,the inner sleeve 612 is inserted into the outer sleeve 614, as shown inFIG. 17, and moved longitudinally relative thereto such that the ribs634 are slid into the rib receiving recesses 635 of the outer sleeve614. Once the container 602 has been assembled, as shown in FIG. 18, thecontainer 602 may be used to collect bone graft material in the samemanner described above in regard to the system 100. It will beunderstood by those of skill in the art that in an alternativeembodiment two-part assembly embodiment, the ribs 634 may extendradially inward from the inner surface 626 of the outer sleeve 614 to beslidably received within rib receiving recesses 635 formed along _(t)heouter surface 630 of the inner sleeve 612.

As shown in FIG. 19, a container 702 according to a further embodimentof the invention is substantially similar to the container 102 describedabove except that inner and outer sleeves 712, 714 thereof are formed ofa mesh material fitted over a frame structure 713 to provide stabilityto the container 702. The mesh material permits fluid and/or nutrientsto flow through the container 702 while preventing the bone graftmaterial from falling therethrough. The mesh material may be formed of,for example, a woven band or a strip of PCL bonded to the framestructure 713 of the container 702.

It will be understood by those of skill in the art that any of theembodiments of the containers 102-702 described above may be sized andshaped for the treatment of various bones. For example, as shown in across-sectional depiction of a container 802 in FIG. 20, the container802 is particularly suited for tibial applications, comprising an innersleeve 812 substantially circular in cross-section and an outer sleeve814 that is substantially triangular in cross-section. In a preferredembodiment, the inner and outer sleeves 812, 814 may be connected bythree ribs 834 extending longitudinally therebetween, with each rib 832extending from a corner of the substantially triangular outer sleeve 814to an outer surface of the inner sleeve 812 to form three sections ofspace 832 between the inner and outer sleeves 812, 814. It will beunderstood by those of skill in the art that the container 802 mayinclude any number of ribs 834. For example, the container 802 mayinclude two ribs 834 such that two sections of space 832 are createdbetween the inner and outer sleeves 812, 814.

In another embodiment, a container 902, as shown in FIGS. 21-22, issized and shape for mandibular applications. The container 902 may havean irregular cross-section, as shown in FIG. 21, and may comprise asingle sleeve 912 extending longitudinally from a proximal end 916 to adistal end 918. Although the container 902 is shown as including asingle sleeve, it will be understood by those of skill in the art thatthe container 902 may include any of the features described above inregard to the inner and outer sleeves of the above-describedembodiments, including a second sleeve. For example, the container 902may include holds 958 for permitting nutrients and/or fluid to passtherethrough and slits 976 extending therethrough around a portion of aperimeter thereof for flexibility.

It will be understood by those of skill in the art that any of thefeatures described above in regard to the various embodiments of thecontainer 102-902 may be combined in a single container, if so desired.For example, as shown in FIG. 23, a container 1002 may include an innersleeve 1012 longer than an outer sleeve 1014 such that a proximal end1016 of the inner sleeve 1012 extends proximally past a proximal end1018 of the outer sleeve 1014 and a distal end 1018 of the inner sleeve1012 extends distally past a distal end 1024 of the outer sleeve 1014.The proximal and distal ends 1016, 1018 arc configured to be insertedinto a canal of a defective bone and may further include one or morelongitudinal slits 1078, 1080 extending through a portion thereof,respectively, to provide a friction fit within the canal of the bone.The container 1002 may also include holes 1058 for permitting flowtherethrough and horizontal slits 1076 providing flexibility extendingthrough at least one of the inner and outer sleeve 1012, 1014. Inaddition, the container may also include a reinforced section 1082extending along a length of the outer sleeve 1014 for permittingfixation elements to be drilled and/or inserted therethrough. It will beunderstood by those of skill in the art that other combinations offeatures, shapes, sizes, etc. described with respect to the exemplaryembodiments of the present invention, which are not specificallydescribed herein, are also possible,

As shown in FIGS. 24-25, according to another embodiment of the presentinvention, a graft container 1102 substantially similar to the graftcontainer 102 described above, is divided along a length thereof to formtwo clam-shell portions 1102 a, 1102 b connected to one another via ahinge 1174. The first and second clam-shell portions 1102 a, 1102 b maypivot with respect to one another about the hinge 1174 such thatcontainer 1102 is movable between an open configuration in which thefirst and second clam-shell portions 1102 a, 1102 b are pivoted awayfrom one another and a closed configuration, in which the clam-shellportions 1102 a, 1102 b are pivoted into engagement with one another.Thus, the container 1102 may be applied to a target portion of a boneafter insertion of an intramedullary rod. In particular, in the openconfiguration, the container 1102 may be positioned around a portion ofthe intramedullary rod. Once the container 1102 has been properlypositioned, the container 1102 may be moved to the closed configurationsuch that the intramedullary rod is encased between the first and secondclam-shell portions 1102 a, 1102 b.

Similarly to the container 102, each of the first and second portions1102 a, 1102 b includes an inner sleeve portion 1112 a, 1112 b and anouter sleeve portion 1114 a, 1114 b forming a space 1132 a, 1132 btherebetween for holding bone graft material therein. A channel 1176formed between the inner sleeve portions 1112 a, 1112 b, when the innersleeve portions 1112 a, 1112 b are joined together in the closedconfiguration, is sized and shaped to accommodate the intramedullary rodtherein. Thus, when the container 1102 is being positioned around theintramedullary rod, the container 1102 is positioned such that the rodis seated in one portion of the channel 1176. The container 1102 maythen be moved to the closed configuration such that the rod is encasedin the opening 1176 between the first and second clam-shell portions1102 a, 1102 b. The inner sleeve portions 1112 a, 1112 b and outersleeve portions 1114 a, 1114 b may also include a plurality of openings1158 extending thcrethrough to permit nutrients to flow into and out ofthe container 1112. The plurality of openings 1158 may be formed assubstantially circular holes, as shown in the embodiment of FIG. 1,and/or slotted perforations, as shown in the embodiment of FIG. 13.

The hinge 1174 may be arranged on the container 1102 to join opposingedges of the outer sleeve portions 1114 a, 1114 b of the first andsecond clam-shell portions 1102 a, 1102 b together. The hinge 1174 maybe, for example, a bonded flexible or woven resorbable PLA strip appliedto the opposing edges. Alternatively, the hinge 1174 may be a suturejoining the opposing edges together. It will be understood by those ofskill in the art, however, that the hinge 1174 may be any of a varietyof elements joining opposing edges of the outer sleeves portions 1114 a,1114 b of the clam-shell portions 1102 a, 1102 b together, Similarly,once the container 1102 has been applied over a portion of theintramedullary rod in a target portion of bone and moved to the closedconfiguration, the clam-shell portions 1102 a, 1102 b may be similarlymaintained in the closed configuration by applying a woven strip orsuturing opposing edges of the open side of the clam-shell portions 1102a, 1102 b together. The hinge 1174 may also be formed of a resorbablematerial. It will be understood by those of skill in the art, however,that the container 1102 may be maintained in the closed configurationusing any known locking mechanism or joining element known in the art.It will also be understood by those of skill in the art, the first andsecond clam-shell portions 1102 a, 1102 b may not pivot about the hinge1174. Rather, the first and second clam-shell portions 1102 a, 1102 bmay be positioned along the desired portion of bone and joined togetherin a desired configuration via a suture and or a woven strip.

The container 1102 may be similarly used with the graft collectionsystem 101, described above in regard to the graft system 100, tocollect graft material in the spaces 1132 a, 1132 b, Since the container1102 is substantially similar to the container 102 in the closedconfiguration, the container 1102 is simply moved to the closedconfiguration and placed in the canister 104, as described above,

Where the container 1102 is being used to treat a bone such as, forexample, a femur, each of the first and second portions 1102 a, 1102 bmay be substantially semi-cylindrical and attached on one side via thehinge 1174 so that when the container 1102 is in the closedconfiguration, the container 1102 is substantially cylindrical. It willbe understood by those of skill in the art, however, that the container1102 may be any of a variety of shapes and sizes selected to fit atarget bone. For example, as shown in FIG. 26, a container 1102′ may bea substantially triangular shape suited for tibial applications. Thecontainer 1102′, may be substantially similar to the container 802described above and shown in FIG. 20, but divided along a length thereofto form two clam-shell portions 1102 a ′, 1102 b ′.

As shown in FIGS. 27 and 28, a container 1202 is substantially similarto the container 1102, described above, comprising two clam-shellportions 1202 a, 1202 b which pivot with respect to one another about ahinge 1274 between an open configuration and a closed configuration.Similarly to the container 1102, the first and second clam-shellportions 1202 a, 1202 b include inner sleeve portion 1212 a, 1212 b andouter sleeve portions 1214 a, 1214 b forming a space 1232 a, 1232 btherebetween for holding bone graft material therein, The container 1202may be positioned over a target portion of bone in the openconfiguration with the first and second clam-shell portions 1202 a, 1202b pivoted away from one another, and moved to the closed configurationwith the first and second clam-shell portions 1202 a, 1202 b pivotedtoward one another to enclose an intramedullary nail between the innersleeve portions 1212 a, 1212 b. Inner sleeve portions 1212 a, 1212 b ofthe first and second clam-shell portions 1202 a, 1202 b, respectively,are formed of a flexible material such as, for example, polycaprolactone(PCL), such that the inner sleeve portions 1212 a, 1212 b wrap about theintramedullary nail as it is applied to a target portion of a bonewithout interference that might result from the application of a rigidstructure over the nail. That is, the flexible nature of the innersleeve portions 1212 a and 1212 b allow the container 1202 to be placedover a bone even where the nail is not centered within the bone—i.e.,the flexibility of the inner sleeve portions 1212 a and 1212 b allowsthe container 1202 to adapt to a situation where a variation in thepositioning of the medullary canal in a portion of bone to be treatedhas moved the nail. Thus, such a container 1202 may be used in moresituations than a rigid container. The outer sleeve portions 1214 a,1214 b are preferably rigid, but may also be formed of a flexiblematerial. Although not shown, the inner and/or outer sleeve portions1212 a, 1212 b, 1214 a, 1214 b may also include pores extendingtherethrough to permit evacuation of blood and irrigation fluids duringgraft material collection, while also permitting nutrients to flow intothe bone graft material collected in the space 1232 a, 1232 b fromradially outside and inside the container 1202.

As shown in FIG. 27, the container 1202 may also include a tab 1282extending longitudinally from each of proximal and/or distal ends 1222,1224, respectively, of the outer sleeve portions 1214 a, 1214 b. Tabs1282 may be attached to ends of the target bone, between which thecontainer 1202 is being positioned. The tabs 1282 may be attached to thebone via, for example, resorbable tacks, to enhance stabilization onbone ends. In a further embodiment, as shown in Fig, 28, the container1202 may also include proximal and/or distal flexible cuffs 1284attached to the proximal and/or distal ends 1222, 1224 of the outersleeve portions 1214 a, 1214 b for additional stabilization. Theflexible cuffs 1284 may be formed of any flexible material such as, forexample, PCL, and are configured to extend about bone ends between whichthe container 1202 is positioned. The cuffs 1284 may be particularlyuseful for fixing the container 1202 between bone ends that are uneven.The cuffs 1284 may be closed about the bone ends using for example, asuture closing.

Although the outer sleeve portions 1214 a, 1214 b are shown to have asubstantially triangular cross-sectional shape in the closedconfiguration, it will be understood by those of skill in the art thatthe outer sleeve portions 1214 a, 1214 b may take any of a variety ofshapes and sizes depending on a type of bone in which the container 1202is desired to be placed within. In addition, although the exemplaryembodiment described above specifically describes a flexible innersleeve in regard to a container including two clam-shell portions, itwill be understood by those of skill in the art that a flexible innersleeve and/or a flexible outer sleeve may be incorporated into any ofthe container embodiments 102-1102 described above.

It will be understood by those of skill in the art that all of thecontainers described above may be utilized with the graft collectionsystem 101, described above with regard to the system 100. Toaccommodate those containers that are not cylindrical such as, forexample, containers 802, 902, 1102′ and 1202, described above, the graftcollection system 101 may further comprise an adaptor 186, as shown inFIG. 29, extending from a proximal end 188 to a distal end 190 andincluding a lumen therethrough. The distal end 190 is sized and shapedto be coupled to a proximal end of the container (e.g., triangular) suchas the container 1202, while the proximal end 188 is sized and shaped(e, g., circular) to be coupled to a portion of the cover 138 such thathone graft material suctioned via the suctioning element 106 is directedinto the graft collection space between the non-cylindrical outer sleeveand the inner sleeve of the container. It will be understood by those ofskill in the art that the adaptor 186 may be available in a variety ofsizes and shapes to accommodate containers suited for any of a varietyof types of bone, such as for the tibial and the mandibularapplications.

According to another exemplary method of the present invention, a custombone graft container 1302, as shown in FIG. 30, may be formed by lasersintering metal or any other suitable material to conform to a patient'sanatomy based on, for example, a CT scan of a target portion of bone. Inan exemplary embodiment, a surgeon may test a plastic model of the graftcontainer 1302 before forming the graft container 1302 out of thedesired metal material. Thus, a plastic model of inner and outer sleeves1312, 1314 may be formed. The plastic model of the inner sleeve 1312 issized and shaped to correspond to a medullary canal (e.g., a size andshape of an intramedullary nail extending therethrough) while theplastic model of the outer sleeve 1314 is sized and shaped to correspondto an exterior surface of the bone. The plastic models may then betested on the patient so that any required changes to the size and shapeof either of the inner and outer sleeves 1312, 1314 of the graftcontainer 1302 may be identified. A final plastic prototype of the innerand outer sleeves 1312, 1314 may be formed, incorporating any requireschanges.

The inner sleeve 1312 may be formed to a shape of the medullary canal ofthe bone and to accommodate an intramedullary nail extendingtherethrough. Where a plastic model has been utilized, the inner sleeve1312 may be sintered to correspond to the final prototype of the innersleeve. The inner sleeve 1312 may be formed to also include alongitudinal slot (not shown) extending therealong such that the innersleeve 1312 may be opened and positioned about the intramedullary nail.An outer sleeve 1314 may be similarly laser sintered from a lasermaterial to conform to the shape of the patient's hone and/or the finalplastic prototype of the plastic model. The outer sleeve 1314 mayinclude proximal and/or distal tabs 1386 extending therefrom andincluding at least one borehole 1387 extending therethrough tofacilitate attachment to an exterior of ends of the bone between whichthe outer sleeve 1314 is positioned. Similarly to the containersdescribed above, the inner and/or outer sleeves 1312, 1314 may he formedwith a plurality of holes 1358 extending therethrough. In anotherexemplary embodiment, the graft container 1302 may, for example, befabricated in similarly appropriate medical grade materials usingadditive manufacturing processes.

The inner and outer sleeves 1312, 1314 may be connected to one anothervia an attachment tab 1334 extending therebetween such that the innersleeve 1312 is positioned around a portion of the intramedullary nailbetween ends of the target area of the bone and the outer sleeve 1314 issimilarly positioned between the ends of the bone. A bone graft materialmay be packed in a space between the inner and outer sleeves 1312, 1314by, for example, packing the material through proximal and/or distalends thereof or through the holes 1358 extending through the outersleeve 1314. The outer sleeve 1314 may be similarly attached to the boneby inserting fixation elements through the boreholes 1387 extendingthrough the tabs 1386. In a further embodiment, a cuff may also beattached to the proximal and/or distal ends 1322, 1324 of the outersleeve 1314. The cuff may be substantially similar to the cuff 1284described above in regard to the container 1202 and may be positioned toextend about ends of the target bone. A suture may be used to fix thecuff about the bone ends.

In an alternate embodiment, the graft container 1302 may only becomprised of the outer sleeve 1314, which is sintered to correspond insize and shape to the target bone of the CT scan. In this embodiment,bone graft material may be packed within the outer sleeve 1314 about theintramedullary nail. As described above, the outer sleeve 1314 may beaffixed to the bone via the boreholes 1387 in the tabs 1386.

It will be understood by those of skill in the art that variousmodifications and variations can be made in the structure andmethodology of the present invention, without departing from the spiritor scope of the invention. Thus, it is intended that the presentinvention cover the modifications and variations of this inventionprovided that they come within the scope of the appended claims andtheir equivalents,

The present invention relates to a method for forming a custom-fit bonegraft container; comprising obtaining a CT image of a bone of a patient;forming a first model of a bone graft container corresponding in sizeand shape to a target portion of the bone based on the CT image;comparing the first model of the bone graft container to the targetportion of the bone to identifying any required changes thereto toconform the first model to the size and shape of the target portion ofthe bone; incorporating any required changes into the first mode to forma first prototype; and laser melting or sintering a metal material toform a custom bone graft container corresponding in size and shape tothe first prototype,

1-14. (canceled)
 15. A device for containing bone graft material,comprising: a first shell member defining a first portion of an innersleeve and a first portion of an outer sleeve to form a first bone graftcollecting space therebetween; a second shell member defining a secondportion of an inner sleeve and a second portion of an outer sleeve toform a second bone graft collecting space therebetween, the first andsecond shell members couplable to one another such that, when the firstand second shell members are coupled to one another in a closedconfiguration, a contour of the outer sleeve substantially matches acontour of an exterior of a bone about which the device is to beemployed.
 16. The device of claim 15, wherein the first and second shellmembers are coupled to one another via a bioresorbable suture.
 17. Thedevice of claim 15, wherein the first and second shell member arecoupled to one another via a hinge such that the first and second shellmembers are movable relative to one another between an openconfiguration and the closed configuration.
 18. The device of claim 17,wherein the hinge is a bonded flexible PLA strip.
 19. The device ofclaim 15, wherein the inner sleeve is formed of a flexible material. 20.The device of claim 19, wherein the flexible material ispolycaprolactone.
 21. The device of claim 15, further comprising a tabextending from one of the proximal and distal ends of the outer sleeve.22. The device of claim 21, wherein the tab includes an openingextending therethrough, the opening sized and shaped to receive afixation element therethrough for fixing the outer sleeve to the bone.23. The device of claim 15, further comprising a flexible cuff attachedto one of the proximal and distal ends of the outer sleeve configured toextend about an end of a portion of bone to which the device is to becoupled.
 24. The device of claim 15, wherein, when the body is in theclosed configuration, a contour of the inner sleeve substantiallymatches a contour of the medullary canal of a bone in which the deviceis to be employed.
 25. The device of claim 15, wherein at least one ofthe inner and outer sleeves includes a plurality of openings extendingtherethrough sized to permit fluids to pass therethrough whilepreventing the passage of bone graft material therethrough.
 26. Thedevice of claim 15, wherein one of the inner and outer sleeves includesa plurality of slits extending through a portion of a circumferencethereof to permit the device to flex along a longitudinal axis thereof.27. A device for containing bone graft material, comprising: a flexibleinner sleeve extending longitudinally from a proximal end to a distalend; and an outer sleeve surrounding the inner sleeve and extendinglongitudinally from a proximal end to a distal end such that a bonegraft collecting space is formed therebetween.
 28. The device of claim27, wherein at least one of the inner and outer sleeves includes aplurality of openings extending therethrough sized to permit fluids topass therethrough while preventing the passage of bone graft materialtherethrough.
 29. The device of claim 27, wherein one of the inner andouter sleeves includes a plurality of slits extending through a portionof a circumference thereof to permit the device to flex along alongitudinal axis thereof.
 30. The device of claim 27, wherein a contourof the outer sleeve is selected to substantially match a contour of anexterior surface of a bone within which the device is to be employed.31. The device of claim 27, wherein the outer sleeve includes areinforced section extending longitudinally along a portion of a lengththereof, the reinforced section having a wall thickness greater thanthat of a remaining portion of the outer sleeve.
 32. The device of claim31, wherein the outer sleeve includes a slot extending through thereinforced section sized to receive a fixation element therethrough. 33.The device of claim 27, wherein the inner and outer sleeves areintegrally formed and connected to one another via a plurality of ribsextending longitudinally therebetween.
 34. The device of claim 27,wherein at least one of the inner and outer sleeves is formed of a meshmaterial which permits fluids to pass therethrough while preventing bonegraft material from passing therethrough.
 35. The device of claim 27,further comprising a tab extending from one of the proximal and distalend of the outer sleeve and including a hole extending therethroughsized and shaped to receive a fixation element for fixing the outersleeve to the bone. 36-50. (canceled)